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Short and long-term menstrual, reproductive, and mental health outcomes after the intrauterine use of chitosan tamponade or the bakri balloon for severe postpartum hemorrhage: an observational study.

Department of Obstetrics, Charité – University Hospital Berlin, Berlin, Germany - 23^rd May 2024

Anna M. Dückelmann , Paulina Hermann, Carolin Biele, Clara Leichtle, Charlotte Waldner,
Thorsten Braun and Wolfgang Henrich.

Objective: This retrospective follow-up study analyzes the effect of intrauterine postpartum hemorrhage (PPH) therapy on menstrual, reproductive, and mental health outcomes.
Methods: All women who delivered at a university hospital between 2016 and 2021 with PPH and who needed intrauterine therapy were included. A questionnaire on well-being, menses, fertility, and reproductive outcomes was mailed to the patients. Those who did not reply were surveyed by telephone.
Results: A total of 214 women treated with chitosan-covered gauze (group A) and 46 women treated with a balloon tamponade (group B) were recruited, and their short-term courses were analyzed. For long-term follow-up, 71 women of group A (33%) and 21 women of group B (46%) could be reached. A total of 89% of group A and 95% of group B had regular menstrual bleeding in the most recent 12months; 27% (group A) and 29% (group B) were trying to conceive again, and all of them did so successfully. There were 12 deliveries, 3 ongoing pregnancies, 3 miscarriages, and 2 terminations of pregnancies (TOP) in group A and 4 deliveries, 1 miscarriage, and 2 TOPs in group B. More than half of our study participants was sorted into grade II or III of the Impact of Events Scale, indicating they experienced clinical impacts in the form of psychological sequelae. One-quarter of patients had symptoms of post-traumatic stress disorder.
Conclusion: Chitosan gauze as well as balloon tamponade appear to have few adverse effects on subsequent menstrual and reproductive function. Women after PPH are at increased risk of long-term adverse psychological outcomes.

https://www.tandfonline.com/doi/pdf/10.1080/14767058.2024.2354382

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Chitosan-covered tamponade for the treatment of postpartum hemorrhage: a registry-based cohort study assessing outcomes and risk factors for treatment failure

BMC Pregnancy Childbirth. 2025 Feb 5;25(1):120. doi: 10.1186/s12884-025-07236-5.

Clara Leichtle ¹, Annette Aigner ^2 3, Carolin Biele ¹, Paulina Hermann ¹, Teresa Dangli ¹, Charlotte Waldner ¹, Thorsten Braun ¹, Wolfgang Henrich ¹, Anna Maria Dückelmann ⁴

Background: Postpartum hemorrhage (PPH) is one of the leading causes of maternal morbidity and mortality worldwide. Intrauterine hemostatic devices are recommended when PPH does not respond to medical treatment. The objective of this study was to assess the factors leading to unsuccessful intrauterine therapy with a chitosan-covered tamponade (CT) for the treatment of PPH and to evaluate clinical outcomes based on real-world data.

Methods: This registry-based cohort study included all women treated with CT for PPH between January 2017 and June 2022 at a university clinic's perinatal department. The endpoint was defined as the failure of CT, indicated by the requirement of further invasive procedures for ongoing hemorrhage after CT application. Medical records were reviewed and binary logistic regressions used to evaluate delivery mode, placenta previa, and placenta accreta spectrum as potential risk factors for CT treatment failure.

Results: The cohort consisted of 230 women, with successful CT treatment in 91.3%. The success rate for mild PPH was 100.0%, for moderate 95.5%, and for severe 84.2%. Five hysterectomies were performed in total. Placenta previa in cesarean sections was identified as the primary risk factor for CT treatment failure, increasing the odds about 7.5-fold (Odds Ratio: 7.48; 95% CI: 1.87-33.15) compared to cesarean sections without placenta previa. Furthermore, delays in CT insertion may also contribute to treatment failure.

Conclusion: CT serves as an intrauterine treatment for medically intractable PPH. Placenta previa significantly increases the risk of CT treatment failure in cesarean sections. Obstetricians should be particularly vigilant in managing patients with placenta previa and consider early use of CT or a combination of procedures.

Trial registration: This study was approved by the local Ethics Committee on 11/10/2021 (EA4/231/21).

https://pubmed.ncbi.nlm.nih.gov/39910452/

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Retrospective analysis study (n=102) on the use of CELOX PPH GAUZE as a treatment for PPH compared with current standard of care

Postpartum Haemorrhage:
CELOX™ PPH Gauze retrospective data analysis report (Charité data).

Henrich, W, Dückelmann A, Giroud D, Sarr Y. Version 1.1 – 19 May 2022.
Retrospective analysis study (n=102)

• Assessment of 102 patients with PPH who did not respond to conventional treatments
• Primary objective: to control uterine bleeding in PPH with CELOX™ PPH
• CELOX™ PPH demonstrated 100% successful haemostasis in all patients with grade 1 and 2 bleeds (up to 2500mls) for all deliveries
• CELOX™ PPH demonstrated 95.7% successful haemostasis in all patients with grade 1 to 3 bleeds (up to 8000mls) for vaginal deliveries
• Following the introduction of CELOX™ PPH the incidence of hysterectomies was significantly reduced (versus standard of care) by 77.8%

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Retrospective cohort study (n=78) comparing outcomes in PPH management using CELOX PPH Gauze versus balloon tamponade

Uterine packing with CELOX™ PPH compared to balloon tamponade for managing postpartum haemorrhage.

Dueckelmann AM, Hinkson L, Nonnenmacher A, Siedentopf JP, Schoenborn I, Weizsaecker K, Kaufner L, Henrich W, Braun T. Eur J Obstet Gynecol Reprod Biol. 2019; 240:151-155.

Retrospective cohort study (n=78)

• Assessment of the effectiveness and safety of CELOX™ PPH versus balloon tamponade for managing severe PPH
• CELOX™ PPH is an excellent treatment for severe PPH and is at least equivalent to the balloon tamponade
• Following the introduction of CELOX™ PPH the incidence of hysterectomies (versus standard of care) was reduced by 50%
• CELOX™ PPH is particularly effective in managing PPH resulting from uterine atony or placenta bed bleeding following vaginal or caesarean section deliveries.
• CELOX™ PPH is especially beneficial for cases involving lower uterine segment atony, placenta previa bed bleeding, and coagulopathy.
• No adverse events or treatment-related morbidity were linked to CELOX™ PPH

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Randomised, prospective evaluation (n=61) comparing the effectiveness of CELOX GAUZE with balloon tamponade in patients with PPH

Comparison of CELOX™ PPH and Bakri balloon in management of primary atonic postpartum Haemorrhage.

Von Beckerath AK, Maul H, Elmohandes AM, Shaaban M, Habib DM, Nasr A, Abdel-Kawi AF. Am J Obstet Gynecol. 2016; 214(1 Suppl 1):S335. [poster presentation]

Randomised, prospective study (n=61)

• Assessment of the effectiveness of intrauterine insertion of CELOX™ PPH in comparison to Bakri balloon
• Failure rate which led to peripartum hysterectomies were 9.7% (3/31) in the CELOX™ PPH group compared to 40% (12/30) in the Bakri balloon group
• CELOX™ PPH is a potentially effective treatment in the management of atonic PPH
• CELOX™ PPH is cost effective, and is easy to use compared to the standard balloon therapy

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Historical, retrospective cohort study evaluation (n=666) comparing the effectiveness of chitosan covered (CELOX PPH) Gauze with balloon tamponade or medical therapy in patients with PPH

Does the use of CELOX™ PPH for postpartum haemorrhage reduce the need for surgical therapy including hysterectomy? A databased historical cohort study.

Biele C, Radtke L, Kaufner L, Hinkson L, Braun T, Henrich W, Dückelmann AM. J Perinat Med. 2022; 50(8):1078-1086.

Retrospective cohort study (n=666)

• Assessment of the effectiveness of CELOX™ PPH in comparison with balloon tamponade, and medical therapy only
• Groups were compared in terms of therapy success, side-effects, and the primary outcome was the need for surgical measures (e.g., hysterectomy)
• No significant differences in the need for surgical therapy between groups.
• CELOX™ PPH group had significantly fewer hysterectomies compared to the balloon tamponade group.
• Following the introduction of CELOX™ PPH, the incidence of PPH-related hysterectomies was significantly reduced by 77.8%.
• No adverse events related to CELOX™ PPH
• CELOX™ PPH is easy to use and cost-effective compared to alternative devices.

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Clinical evaluation (n=98) of chitosan-covered (CELOX PPH) Gauze in patients with PPH

Use of CELOX™ PPH in 98 cases of severe postpartum haemorrhage–a multicenter registry analysis.

Von Beckerath AK, Maul H, Gebauer G, Abdel-Kawi AF, Rolf N, Saade G, Bader W, Kusnierczak D, Berger R, Kienast C, Kienemund J, Schmid B. Am J Obstet Gynecol. 2016; 214(1 Suppl 1):S269. [poster presentation]

Multicentre registry analysis study (n=98)

• Assessment of the potential side effects of CELOX™ PPH, and to assess if the use of CELOX™ PPH reduces the rate of postpartum hysterectomies
• Women with PPH were treated in accordance to guidelines with the addition of uterine packing using CELOX™ PPH
• After the introduction of CELOX™ PPH the rate of postpartum hysterectomies reduced from 0.18% to 0.05% (p=0.0183)
• No adverse events were observed or reported
• CELOX™ PPH is cost-effective and easy to use

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Clinical evaluation (n=65) ofchitosan-covered (CELOX PPH) Gauze in patients with severe PPH (including cases where risk of postpartum hysterectomy is high)

Uterine packing with CELOX™ PPH for control of postpartum Haemorrhage (PPH).

Maul H, Steinmacher S, Saade G, Gebauer G, Rolf N, Schmid B. Am J Obstet Gynecol. 2015; 212(1 Suppl 1):S358-S359. [poster presentation]

Case study series (n=65)

• Objective: to compare a 26 month period before and a 38 month period after the introduction of CELOX™ PPH in the treatment of PPH
• Women with PPH were treated by uterine packing with CELOX™ PPH through the hysterotomy in caesarean delivery, or transvaginally
• CELOX™ PPH is a viable option in the treatment of PPH
• After the introduction of CELOX™ PPH postpartum hysterectomies were significantly reduced (p=0.023)
• CELOX™ PPH can be safely used after both vaginal and caesarean section
• No complications related to CELOX™ PPH treatment were observed
• The use of CELOX™ PPH is inexpensive

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Clinical evaluation (n=35) of chitosan-covered (CELOX™ PPH) gauze in patients with PPH

Uterine packing with CELOX™ PPH for control of postpartum Haemorrhage.

Maul H, Gebauer G, Rolf N, Saade G, Rezniczek G, Schmid B. Am J Obstet Gynecol. 2014; 210(1 Suppl 1):S281-S282. [poster presentation]

Case study series (n=35)

• Objective: to describe 26 months of experience using CELOX™ PPH in the treatment of PPH
• Over comparable periods of time (26 months) and similar number of births (n=5498 vs. n=6222) before and after the introduction of CELOX™ PPH there was a significant reduction in the rate of postpartum hysterectomies (p=0.011)
• CELOX™ PPH is a viable option for the treatment of (severe) PPH
• CELOX™ PPH is easy to apply and can be used after both vaginal and caesarean deliveries and requires no special training
• CELOX™ PPH is inexpensive compared to other treatment options
• No complications related to CELOX™ PPH treatment were observed

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Case studies: use of CELOX™ PPH in patients (n=19) with severe PPH (including cases where risk of postpartum hysterectomy is high)

Uterine packing with CELOX™ PPH for control of postpartum Haemorrhage.

Schmid BC, Rezniczek GA, Rolf N, Saade G, Gebauer G, Maul H.. Am J Obstet Gynecol. 2013; 209(3):225.e1-225.e5.

Case study series (n=19)

• Assessment of the use of CELOX™ PPH in the treatment of PPH
• Women with PPH were treated with uterine packing using CELOX™ PPH either through the hysterotomy, in the case of caesarean delivery or transvaginally
• In all but one case (18/19) bleeding was halted and no further intervention was required
• Over equivalent 18-month periods and with a comparable number of births (3822 vs. 4077) before and after the introduction of CELOX™ PPH, the rate of peripartum hysterectomies was reduced by 75% (p = .044)

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Case studies: use of chitosan (CELOX™ PPH Gauze) in patients with (n=4) life-threatening obstetric bleeding

Uses of CELOX™ PPH for treating different forms of serious obstetrics haemorrhages.

Carles G, Dabiri C, Mchirgui A, Saoudi EO, Hcini N, Pouget K, Seve B, de Matteis B. J Gynecol Obstet Hum Reprod. 2017; 46(9):693-695.

Case study series (n=4)

• Four cases where CELOX™ PPH was used to treat severe obstetric haemorrhage
• Two chitosan variants, in powder and CELOX™ PPH form, were used*
• In all four cases, chitosan effectively resolved the severe obstetric haemorrhage
• Treatment with CELOX™ PPH was inexpensive, and required no training

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Case report: use of chitosan-covered (CELOX™ PPH) Gauze in combination with balloon tamponade for management of PPH

Application of CELOX™ PPH in combination with intrauterine balloon tamponade for postpartum Haemorrhage treatment – Case report of a novel "uterine sandwich" approach.

Seidel V, Braun T, Weizsäcker K, Henrich W. Int J Surg Case Rep. 2018; 48:101-103.

Case report (n=1)

• Presentation of a case of PPH where a novel “uterine sandwich” (a combination of CELOX™ PPH and intrauterine balloon tamponade) used to halt blood loss
• The novel treatment strategy was effective at stopping further blood loss
• The use of the “uterine sandwich” prevented the need for more invasive second stage intervention

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Case report: use of haemostatic combat (CELOX™ PPH) Gauze in a severe case of PPH

Postpartum Haemorrhage: use of CELOX™ PPH.

Schmid BC, Rezniczek GA, Rolf N, Maul H. Am J Obstet Gynecol. 2012; 206(1):e12-e13.

Case report (n=1)

• Reporting of a case of PPH where conservative treatment proved ineffective, and CELOX™ PPH was used
• Tight uterovaginal packing with CELOX™ PPH was performed in an effort to arrest recurring haemorrhage
• CELOX™ PPH achieved haemostasis and remained in place for 36 hours*
• By achieving haemostasis, CELOX™ PPH prevented a seemingly inevitable hysterectomy
• The ease of application and cost-effectiveness of CELOX™ PPH present a promising addition to the treatment options for PPH

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Uterine packing with chitosan-covered tamponade to treat postpartum hemorrhage

American Journal of Obstetrics & Gynecology - Expert Review

Wolfgang Henrich, MD, PhD; Anna Dückelmann, MD; Thorsten Braun, MD, PhD;
Larry Hinkson, MBBS, MD, MRCOG, FRCOG

Postpartum hemorrhage (PPH) causes substantial maternal mortality and morbidity and is responsible for a quarter of all maternal deaths worldwide.1 Conventional use of uterotonics such as oxytocin, prostaglandins, and medications to support coagulation, such as fibrinogen and tranexamic acid, are helpful but may not be sufficient to arrest life-threatening PPH. Blood transfusions, intrauterine balloon tamponade application, invasive techniques, such as compression sutures, and arterial ligation are advanced steps in the management cascade. In extreme cases, a hysterectomy may be necessary to avoid maternal death.

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